PainNCT06790433
Comparison Between the Dentapen and Vibraject
A study testing Vibraject and Dentapen in people with Pain, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial summary
A split-mouth, controlled trial aimed to assess patient-reported pain levels during local anaesthesia administration to the buccal side of the maxillary posterior teeth using Vibraject-assisted injection and the Dentapen® system in its ramp-up mode. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Vibraject and Dentapen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2023to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals classified under American Society of Anesthesiologists classes I and II, indicating a healthy or mild systemic disease status.
- Individuals aged from 18 up to 65 years, encompassing both male and female patients.
- Individuals who required local anesthetic injections bilaterally in the buccal side of the upper posterior teeth. These injections were necessary for various dental procedures, including restorative, endodontic, or prosthodontic treatments, and volunteers as well were to be administered across both sides of upper posterior teeth.
- Individuals must be in good health, not currently taking any medication, and have no contraindications to the use of local anesthesia.
- Individuals who have the ability to understand both oral and written instructions, ensuring effective communication and comprehension throughout the study.
Who cannot join
- Individuals with allergies to local anesthetics, this is to prevent adverse reactions.
- Pregnant or nursing women, this is to avoid any potential risks to their health or that of their infants.
- Individuals who were actively taking drugs that could alter pain perception or anxiety levels, such as nonsteroidal anti-inflammatory drugs, opioids, or antidepressants. This was to ensure that the study's findings on pain perception were not influenced by external substances
- Individuals with heavy alcohol consumption. .
- Patients with active pathologies at the injection site, this is to avoid complications and to ensure the accuracy of the study's results.
- Individuals who could not commit to the study's schedule or were unable to give informed consent. This ensured that all participants were fully aware of and agreeable to the study's procedures and requirements.
- Patients who required intravenous sedation for their dental procedures.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Dental Hospitals - Riyadh Elm University
Riyadh, 84891
About this study
Official title: Comparison Between the Dentapen and Vibraject: a Randomized Clinical Study on the Administration of Local Anaesthesia in Adult Patients.
A split-mouth, controlled trial aimed to assess patient-reported pain levels during local anaesthesia administration to the buccal side of the maxillary posterior teeth using Vibraject-assisted injection and the Dentapen® system in its ramp-up mode.
Pain intensity was evaluated using the Visual Analogue Scale immediately following each injection, and heart rate measurements were recorded before and after each injection. Patient preferences for injection methods were also documented
Read the detailed description
Steps of the Experiment
The experimental protocol was meticulously structured to evaluate the efficacy and patient response to two different local anaesthetic delivery systems. The steps were as follows:
Step I: Before administering a local anaesthetic, the patient's heart rate was checked with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step II: Patients were randomly assigned to get the injection of local anaesthetic at their initial appointment either with the Dentapen system (ramp-up) or with Vibraject. To simplify the protocol, a 27-gauge needle was used for all dental injections with bevel side directly headed to the injected site.
Step III: In the next appointment, after of one hour on a digital timer, the other technique was used for the same patients on the other side. Hence, each patient was given local anaesthesia twice, once with the Dentapen system (ramp-up mode) and once with Vibraject.
Step IV: Immediately after each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain.
Step V: After administering a local anaesthetic, the patient's heart rate was measured with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step VI: After both injections were administered to each patient, they were asked which injection they would prefer by selecting the injection number (first or second) according to their order for each patient.
- Conditions
- Pain
- Being tested
- Vibraject, Dentapen
- Keywords
- dental injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrajectDevice
The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis. The Vibraject was activated after aspiration to deposit the solution slowly at approximately 50 seconds. Following cartridge deposition, the operator adjusted the participant to an upright seated position
DentapenDevice
The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis (needle placement). The Dentapen was activated after aspiration to deposit the solution at a medium rate (1 mL/60 s) using the ramp-up mode. Following cartridge deposition, the operator adjusted the participant to an upright seated position
| Study group | Role | What they receive |
|---|---|---|
| Vibraject | Active comparator | Participants will receive dental injection using Vibraject Receives: Device: Vibraject |
| Dentapen | Active comparator | Participants will receive dental injection using Dentapen Receives: Device: Dentapen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate was measured for the participants using a pulse oximeter
Measured: Immediately after the intervention/procedure (dental anesthesia)
Pain rating scale
After each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain. It is a scale of pain composed of 10 scores from 0 to 10, a higher score indicates greater pain intensity (worse outcome).
Measured: 3 minutes after the intervention/procedure (dental anesthesia)
Participant's future preference
The participants were asked using a simple questionnaire to state their preference for the delivery system of future injections
Measured: 5 minutes after the intervention/procedure (dental anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Oct 2023
- Primary completion30 Dec 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ِAmmar AbuMostafa, MSc, Study director, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790433
- Sponsor's protocol ID
- Dr Ammar's - Anesthesia 2025
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Dentapen and Vibraject: a Randomized Clinical Study on the Administration of Local Anaesthesia in Adult Patients.
- ClinicalTrials.gov ID
- NCT06790433
- Acronym / sponsor ID
- Dr Ammar's - Anesthesia 2025
- Conditions
- Pain
- Keywords
- dental injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A split-mouth, controlled trial aimed to assess patient-reported pain levels during local anaesthesia administration to the buccal side of the maxillary posterior teeth using Vibraject-assisted injection and the Dentapen® system in its ramp-up mode.
Pain intensity was evaluated using the Visual Analogue Scale immediately following each injection, and heart rate measurements were recorded before and after each injection. Patient preferences for injection methods were also documented
Detailed description
Steps of the Experiment
The experimental protocol was meticulously structured to evaluate the efficacy and patient response to two different local anaesthetic delivery systems. The steps were as follows:
Step I: Before administering a local anaesthetic, the patient's heart rate was checked with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step II: Patients were randomly assigned to get the injection of local anaesthetic at their initial appointment either with the Dentapen system (ramp-up) or with Vibraject. To simplify the protocol, a 27-gauge needle was used for all dental injections with bevel side directly headed to the injected site.
Step III: In the next appointment, after of one hour on a digital timer, the other technique was used for the same patients on the other side. Hence, each patient was given local anaesthesia twice, once with the Dentapen system (ramp-up mode) and once with Vibraject.
Step IV: Immediately after each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain.
Step V: After administering a local anaesthetic, the patient's heart rate was measured with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step VI: After both injections were administered to each patient, they were asked which injection they would prefer by selecting the injection number (first or second) according to their order for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibraject | Active comparator | Device: VibrajectParticipants will receive dental injection using Vibraject |
| Dentapen | Active comparator | Device: DentapenParticipants will receive dental injection using Dentapen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals classified under American Society of Anesthesiologists classes I and II, indicating a healthy or mild systemic disease status.
- Individuals aged from 18 up to 65 years, encompassing both male and female patients.
- Individuals who required local anesthetic injections bilaterally in the buccal side of the upper posterior teeth. These injections were necessary for various dental procedures, including restorative, endodontic, or prosthodontic treatments, and volunteers as well were to be administered across both sides of upper posterior teeth.
- Individuals must be in good health, not currently taking any medication, and have no contraindications to the use of local anesthesia.
- Individuals who have the ability to understand both oral and written instructions, ensuring effective communication and comprehension throughout the study.
Key exclusion criteria (7 listed)
- Individuals with allergies to local anesthetics, this is to prevent adverse reactions.
- Pregnant or nursing women, this is to avoid any potential risks to their health or that of their infants.
- Individuals who were actively taking drugs that could alter pain perception or anxiety levels, such as nonsteroidal anti-inflammatory drugs, opioids, or antidepressants. This was to ensure that the study's findings on pain perception were not influenced by external substances
- Individuals with heavy alcohol consumption. .
- Patients with active pathologies at the injection site, this is to avoid complications and to ensure the accuracy of the study's results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibrajectThe needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis. The Vibraject was activated after aspiration to deposit the solution slowly at approximately 50 seconds. Following cartridge deposition, the operator adjusted the participant to an upright seated position | Device | Vibraject |
| DentapenThe needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis (needle placement). The Dentapen was activated after aspiration to deposit the solution at a medium rate (1 mL/60 s) using the ramp-up mode. Following cartridge deposition, the operator adjusted the participant to an upright seated position | Device | Dentapen |
Primary outcome
Heart rate
Time frame: Immediately after the intervention/procedure (dental anesthesia)
Heart rate was measured for the participants using a pulse oximeter
Pain rating scale
Time frame: 3 minutes after the intervention/procedure (dental anesthesia)
After each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain. It is a scale of pain composed of 10 scores from 0 to 10, a higher score indicates greater pain intensity (worse outcome).
Participant's future preference
Time frame: 5 minutes after the intervention/procedure (dental anesthesia)
The participants were asked using a simple questionnaire to state their preference for the delivery system of future injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ِAmmar AbuMostafa, MSc study director
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibraject and Dentapen in people with Pain, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Immediately after the intervention/procedure (dental anesthesia)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.